Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106639
Status:
COMPLETED
Last Update Posted:
2013-03-12
First Post:
2005-03-28
Brief Title:
A 6-Month Study Of CP-690550 Versus Tacrolimus In Kidney Transplant Patients
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A 6-Month Phase 2 Multicenter Randomized Open-Label Comparative Study Of 2 Dose Levels Of CP-690550 Administered Concomitantly With IL-2 Receptor Antagonist Induction Therapy Mycophenolate Mofetil And Corticosteroids Versus A Tacrolimus-Based Immunosuppressive Regimen For The Prevention Of Allograft Rejection In De Novo Renal Allograft Recipients
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of CP-690550 15 mg twice daily and 30 mg twice against tacrolimus in combination with basiliximab induction mycophenolate mofetil and corticosteroids in kidney transplant patients Stage 1 was to randomize approximately 54 subjects After all Stage 1 subjects had completed 6 months of treatment Stage 2 was to randomize an additional 195 subjects to the same treatment groups
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None